U.S. patent application number 17/232768 was filed with the patent office on 2021-10-21 for tube changer device and methods of use thereof.
The applicant listed for this patent is University of Florida Research Foundation, Inc.. Invention is credited to Nikolaus Gravenstein, John Everett Martin, Tomas D. Martin.
Application Number | 20210322700 17/232768 |
Document ID | / |
Family ID | 1000005540891 |
Filed Date | 2021-10-21 |
United States Patent
Application |
20210322700 |
Kind Code |
A1 |
Gravenstein; Nikolaus ; et
al. |
October 21, 2021 |
TUBE CHANGER DEVICE AND METHODS OF USE THEREOF
Abstract
Various embodiments of a tube changer device and methods of use
are described herein. A tube changer device to aid in placement or
replacement of an endotracheal tube including tubular shaft having
a hollow interior forming a main lumen extending from a proximal
end to a distal end and a dilator portion at the distal end. The
dilator portion having a tapered profile with an outer diameter
that varies along a length measured from a junction point on the
tubular shaft to a blunt tip. The main lumen extending through the
dilator portion to the blunt tip. The tube changer device
configured to be slidably received within the endotracheal tube.
The tubular shaft can be flexible. The tube changer device can be
used with or without a stylet for the placement or replacement of
an endotracheal tube.
Inventors: |
Gravenstein; Nikolaus;
(Gainesville, FL) ; Martin; Tomas D.; (Orlando,
FL) ; Martin; John Everett; (Gainesville,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
University of Florida Research Foundation, Inc. |
Gainesville |
FL |
US |
|
|
Family ID: |
1000005540891 |
Appl. No.: |
17/232768 |
Filed: |
April 16, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
63010835 |
Apr 16, 2020 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2025/0687 20130101;
A61M 25/0102 20130101; A61M 16/0488 20130101; A61M 2025/0004
20130101; A61M 25/1018 20130101 |
International
Class: |
A61M 16/04 20060101
A61M016/04 |
Claims
1. A tube changer device to aid in placement or replacement of an
intubation catheter, the device comprising: a tubular shaft having
a hollow interior forming a main lumen extending from a proximal
end to a distal end; and a dilator portion at the distal end, the
dilator portion having a tapered profile with an outer diameter
that varies along a dilator length of the dilator portion, the
dilator length being measured from a junction point of the dilator
portion on the tubular shaft to a blunt tip of the dilator portion,
the main lumen extending through the dilator portion to the blunt
tip, wherein the device is configured to be slidably received
within the intubation catheter.
2. The tube changer device of claim 1, wherein the dilator length
of the dilator portion of the device is greater than a distal
portion of the intubation catheter, the distal portion of the
intubation catheter comprising a bevel tip and a distal wall
opening of the intubation catheter.
3. The tube changer device of claim 2, wherein, when inserted in
the intubation catheter to the distal portion of the intubation
catheter, the dilator portion is configured to cover the distal
wall opening of the intubation catheter with the blunt tip of the
dilator portion extending to or past the bevel tip of the
intubation catheter.
4. The tube changer device of claim 1, wherein the dilator portion
has a prolate spheroid or an ovoid shape.
5. The tube changer device of claim 1, wherein the outer diameter
of the dilator portion has a maximum diameter configured to fit an
inner diameter of the intubation catheter.
6. The tube changer device of claim 1, wherein the dilator portion
has a maximum outer diameter ranging from about 2.0 mm to about
10.5 mm.
7. The tube changer device of claim 1, wherein the main lumen has
an inner diameter configured to slidably receive a stylet.
8. The tube changer device of claim 1, wherein the tubular shaft is
flexible.
9. The tube changer device of claim 1, wherein the dilator portion
is formed in one piece with the tubular shaft.
10. The tube changer device of claim 1, wherein the dilator portion
is secured to the tubular shaft.
11. The tube changer device of claim 1, wherein the dilator portion
comprises polyurethane or polyvinyl chloride material.
12. The tube changer device of claim 1, wherein the dilator portion
is inflatable.
13. The tube changer device of claim 1, further comprising an
inflation lumen within a sidewall of the tubular shaft, the
inflation lumen configured to deliver air between an inflation port
at the proximal end and the dilator portion to inflate or deflate
the dilator portion.
14. A method of intubation catheter placement, comprising:
inserting a distal end of a tube changer device into the proximal
end of the lumen of the first intubation catheter, the tube changer
device comprising: a tubular shaft having a hollow interior forming
a main lumen extending from a proximal end to a distal end; and a
dilator portion at the distal end, the dilator portion having a
tapered profile with an outer diameter that varies along a dilator
length measured from a junction point on the tubular shaft to a
blunt tip, the main lumen extending through the dilator portion to
the blunt tip; advancing the tube changer device through the lumen
of the first intubation catheter until the blunt tip of the dilator
portion of the tube changer device is positioned substantially
aligned with the distal end of the first intubation catheter;
holding the tube changer device in position; removing the first
intubation catheter by sliding the first intubation catheter over
the tube changer device; placing a distal end of a second
intubation catheter around the proximal end of the tube changer
device; advancing the second intubation catheter guided by the tube
changer device until a distal portion of the second intubation
catheter surrounds the dilator portion of the tube changer device;
holding the second intubation catheter in position; and removing
the tube changer device from the second intubation catheter.
15. The method of claim 14, further comprising inserting a stylet
into the lumen of the first intubation catheter to use a guide,
wherein: inserting a distal end of the tube changer device into the
proximal end of the lumen of the first intubation catheter
comprises threading the tube changer device over the stylet, and
removing the tube changer device from the second intubation
catheter comprises removing the stylet with the tube changer
device.
16. A method of intubation catheter placement, comprising:
positioning a tube changer device within a lumen of a replacement
intubation catheter, the tube changer device comprising: a tubular
shaft having a hollow interior forming a main lumen extending from
a proximal end to a distal end; and a dilator portion at the distal
end, the dilator portion having a tapered profile with an outer
diameter that varies along a dilator length measured from a
junction point on the tubular shaft to a blunt tip, the main lumen
extending through the dilator portion to the blunt tip; wherein the
tube changer device is configured to be slidably received within
the replacement intubation catheter and the blunt tip of the
dilator portion of the tube changer device is positioned
substantially aligned with the distal end of the replacement
intubation catheter; advancing, together, the tube changer device
and the replacement intubation catheter until the blunt tip of the
tube changer device reaches a position; holding the replacement
intubation catheter in position; and removing the tube changer
device from the replacement intubation catheter.
17. The method of claim 16, further comprising: inserting a stylet
into the lumen of the existing intubation catheter to use a guide;
advancing, together, the tube changer device and the intubation
catheter guided by the stylet until the blunt tip of the tube
changer device reaches a position; holding the replacement
intubation catheter in position; and removing the tube changer
device and stylet by sliding the tube changer device through the
lumen of the replacement intubation catheter.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application No. 63/010,835, filed Apr. 16, 2020, the entire
contents of which is hereby incorporated herein by reference.
BACKGROUND
[0002] Endotracheal tubes are commonly used for airway management
in the settings of general anesthesia, critical care, mechanical
ventilation, and emergency medicine. An endotracheal tube is a
catheter that is inserted into the trachea for the primary purpose
of establishing and maintaining a patent airway and to ensure the
adequate exchange of oxygen and carbon dioxide. Under certain
conditions, an endotracheal tube may need to be replaced or
exchanged for continued ventilation of a patient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0003] For a more complete understanding of the embodiments and the
advantages thereof, reference is now made to the following
description, in conjunction with the accompanying figures briefly
described as follows:
[0004] FIG. 1 illustrates an example of a tube changer device
according to various embodiments described herein.
[0005] FIG. 2 illustrates an example a tube changer device shown
threaded onto a stylet and positioned within an endotracheal tube
according to various embodiments described herein.
[0006] FIG. 3 illustrates an example method for replacing an
endotracheal tube using the tube changer device of FIG. 1 according
to various embodiments described herein.
[0007] FIG. 4 illustrates an example method for placing an
endotracheal tube using the tube changer device of FIG. 1 according
to various embodiments described herein.
[0008] The drawings illustrate only example embodiments and are
therefore not to be considered limiting of the scope of the
embodiments described herein, as other embodiments are within the
scope of this disclosure. The elements and features shown in the
drawings are not necessarily drawn to scale, emphasis instead being
placed upon clearly illustrating the principles of the embodiments.
Additionally, certain dimensions or positionings may be exaggerated
to help visually convey certain principles. In the drawings,
similar reference numerals between figures designate like or
corresponding, but not necessarily the same, elements.
DETAILED DESCRIPTION
[0009] An endotracheal tube (ETT) is a particular type of catheter
that is used for airway management in the settings of general
anesthesia, critical care, mechanical ventilation, and emergency
medicine to establish and maintain a patent airway and to ensure
the adequate exchange of oxygen and carbon dioxide. A medical
procedure commonly known as intubation involves inserting the ETT
(also referred to herein as a tube, catheter, and/or intubation
catheter) via a patient's oral or nasal passage to provide a
passageway to a lung or lungs for ventilation. Once a patient has
been intubated, it may be necessary to replace or exchange the
catheter due to improper placement, cuff malfunction, or to change
the size or type of ETT. For example, an endobronchial tube used
during surgery may need to be exchanged for an endotracheal tube
when there is expected to be prolonged ventilation of the patient
after surgery.
[0010] Most endotracheal tubes have a bevel tip and an opening in a
side wall near the tip. Complications can occur during placement of
an endotracheal tube such as lacerations, damage to the vocal
cords, bleeding, injury to the throat or trachea, or other trauma
to the upper airway. This can further complicate the care and
recovery of the patient. Replacement of an existing ETT can be
particularly difficult due to edema or swelling. Once an ETT is
removed, there is a possibility that the airway may close. In such
a case, there is a need to keep the airway passage open to replace
the tube without causing trauma to the pharynx, larynx, or vocal
cords.
[0011] When the visualization of the vocal cords is difficult, a
stylet or bougie can be inserted into the airway and used as a
guide to advance an ETT though the passage to proper placement. A
stylet or bougie, such as an Eschmann stylet, is a coated,
malleable, elongated cylinder and relatively smaller in diameter as
compared to an ETT, which can facilitate passage through the
airway. Conventional stylets can be rigid and/or be configured with
an angled tip or bend in the stylet. While a stylet or bougie can
be used for an initial placement of an ETT, it can also be used as
a guide for the replacement of an ETT. For replacement of a tube,
the stylet or bougie can be inserted through an existing ETT
positioned in the patient's airway, after which the ETT is
withdrawn with the stylet or bougie left in place. The replacement
ETT is guided over the stylet past the arytenoids and vocal cords
and positioned. The stylet or bougie is then removed for the
patient to be ventilated through the replaced ETT.
[0012] In the context outlined above, the embodiments described
herein are directed to a tube changer device configured to aid in
the placement or replacement of an endotracheal tube in a patient.
The tube changer device is hollow and flexible with a tapered
distal end configured to minimize trauma during placement of the
ETT. When inserted in an endotracheal tube, the tapered distal
dilator portion of the tube changer device is configured to cover
the distal wall opening of the endotracheal tube and the blunt tip
of the dilator portion extends to or past the bevel tip of the
endotracheal tube to provide a blunted end as the endotracheal tube
is placed. The tube changer device provides an alternative to
conventional stylets used for tube exchanges, including an Eschmann
stylet and the like. In some embodiments, the tube changer device
can be used to place or replace an ETT. In some embodiments, the
tube changer device can be used in conjunction with a stylet to
place or replace an ETT. When being used as guide as an alternative
or in conjunction with a stylet, the tapered distal dilator portion
of the tube changer device can also push away or through a
constricted passage at a critical location and a limited airway
during the procedure.
[0013] FIG. 1 illustrates an example of a tube changer device 100.
The tube changer device 100, having a proximal end 101 and distal
end 102, includes a flexible tubular body 103 and a dilator portion
106 forming a blunt tip 107 at the distal end 102 of the tube
changer device 100. The flexible tubular body 103 is hollow and the
dilator portion 106 can be formed in or secured to the flexible
tubular body 103, such that a main lumen 109 extends from the
proximal end 101 of the tube changer device 100 to an open distal
end 102 at the blunt tip 107 of the dilator portion 106. The
flexible tubular body 103 can be formed from polyurethane,
polyvinyl chloride, or similar biocompatible materials. The dilator
portion 106 can have a tapered profile with an outer diameter
(OD.sub.D) that varies along a length (L) measured from a junction
point 104 on the flexible tubular body 103 to the blunt tip 107 at
the distal end 102. The main lumen 109 has an interior diameter
(ID). The dilator portion 106 can have a maximum diameter between
the junction point and the distal end 102 forming a tapered
profile.
[0014] FIG. 2 illustrates the tube changer device 100 of FIG. 1
inserted in an intubation catheter 200 and threaded over a stylet
300. The tube changer device 100 can be used with or without a
stylet 300. As shown, an example of an intubation catheter 200 has
a distal portion 202 that includes a bevel tip 203 and a distal
wall opening 206 on a side wall 212 of the intubation catheter 200.
The intubation catheter 200 has an inner diameter (ID.sub.ETT) and
outer diameter (OD.sub.ETT) forming a single lumen 209. In this
illustration, the tube changer device 100 is positioned with the
dilator portion 106 extending beyond the bevel tip 203 of the
intubation catheter 200. The dilator portion 106 of the tube
changer device 100 can be configured to fit within the intubation
catheter 200 to blunt the edges of the bevel open tip 203 to
minimize trauma to the patient as the tube 200 is being placed. The
dilator portion 106 can also blunt edges of the distal wall opening
206. The distal end 102 of the tube changer device 100 can be
configured to be slidably received within an intubation catheter
200. The maximum diameter of the dilator portion 106 can be about
equal to an inner diameter of the intubation catheter, wherein the
dilator portion 106 can slide within the lumen 209 of the
intubation catheter 200. The maximum diameter of the dilator
portion 106 can be greater than an inner diameter of the intubation
catheter and configured to compress or deflate to slide within the
intubation catheter. In an example, the dilator portion 106 can
deform such that it can slide within the lumen 209 of the
intubation catheter 200, then fill the space to blunt the bevel tip
203 and a distal wall opening 206.
[0015] In some embodiments, the dilator portion 106 comprises a
solid tapered portion configured to provide a blunt tip 107. In
some embodiments, the dilator portion 106 can have a substantially
prolate spheroid or ovoid shape. The dilator portion 106 can be
formed from material firm enough to push away or through a
constricted passage, yet soft enough to protect the tissues of the
airway. For example, the dilator portion 106 can be formed from
polyurethane, polyvinyl chloride, or similar biocompatible
materials. In some embodiments, the dilator portion 106 can be made
of a sponge-like compressible material that enlarges
circumferentially into the available space to a predetermined size
limit. In some embodiments, the dilator portion 106 comprises an
inflatable portion that can be inflated by a syringe via an
inflation lumen.
[0016] The device can be sized and configured with measurements to
correspond with a range of sizes of endotracheal tubes to be
placed. When inserted in the intubation catheter 200 to the distal
portion, the dilator portion of the device is configured to cover
the distal wall opening of the intubation catheter and the blunt
tip of the dilator portion extends to or past the bevel tip of the
intubation catheter.
[0017] For example, the device can be configured to fit within an
intubation catheter or ETT having an internal diameter ranging from
about 2.0 mm to about 10.5 mm. As such, the dilator portion 106 of
the tube changer device 100 can be sized to slidably fit within the
inner diameter of a specified ETT, with a maximum outer diameter
ranging from about 2.0 mm to about 10.5 mm. The length of the tube
changer device 100 can be substantially longer than a standard ETT
to allow the extraction of the tube changer device 100 after
placement of the ETT. The length of the tube changer device 110 can
range from about 50 cm to about 70 cm, depending on the
configuration.
[0018] In an example, the tube changer device 100 can be used with
both an intubation catheter 200 and a stylet 300. The stylet 300
can be a conventional stylet or bougie, such as an Eschmann stylet.
In some embodiments, the stylet 300 can be configured to slide
within the lumen 109 of the tube changer 100. As shown in FIG. 2,
the lumen 109 of the tube changer device 100 can be configured with
an inner diameter (ID.sub.D) that can slidably receive an outer
diameter (OD.sub.S) the stylet 300. The main lumen 109 can be sized
to correspond with the outer diameter of the stylet 300. The tube
changer device 100 and the intubation catheter 200 can be guided as
a unit over the stylet 300 that has been placed in the patient's
airway. Alternately, the stylet 300 can be used as a guide for
placement of the tube changer device 100, then the tube changer
device 100 used as a guide for placement of the intubation catheter
200.
[0019] The tube changer 100 can be used with or without a stylet
300. The tube changer device 100 can be used in place of a stylet
or bougie for ETT placement or replacement. The tube changer device
100 can be used in conjunction with a stylet or bougie to aid in
opening constricted passages. The tube changer device 100 can be
inserted in an ETT to blunt the edges of the distal wall opening
206 and open bevel tip 203 of an ETT to minimize trauma as the tube
changer device 100 and ETT 200, together, are advanced over a
stylet 300.
[0020] For example, the tube changer 100 can be used with only an
intubation catheter 200. The tube changer device 100 can be
configured to be used in place of a stylet or bougie. The tube
changer device 100 can be configured to have a dilator portion 106
with a diameter corresponding to the inner diameter of the
replacement tube. The dilator portion 106 of the tube changer
device 100 can be guided through an existing ETT to provide a
guided passage for a replacement ETT. In this case, the dilator
portion 106 can be placed to hold open an airway for a patient at
risk of life-threatening loss of airway. While the patient may
still be at risk of trauma from the bevel tip of the ETT being
guided through a swollen or compromised passage, the larger
diameter dilator portion 106 can resist constriction at a critical
location and the main lumen 103 can maintain a limited airway
during the procedure. When the replacement ETT is advanced to the
position of the dilator portion 106, the bevel tip of the ETT is
gently guided over the tapered end of the tube changer device 100
and into position. The tube changer device 100 can then be removed
from the replacement tube.
[0021] FIG. 3 shows an example method for placement of an ETT or
intubation catheter. At step 302, determine that an existing ETT or
first intubation catheter placed in an airway of a patient requires
replacement. The first intubation catheter having a lumen extending
from a proximal end exterior to the patient to a distal end placed
within the patient. At step 304, inserting a distal end of a tube
changer device 100 into the proximal end of the lumen of the first
intubation catheter. At step 306, the tube changer device 100 is
advanced through lumen of the first intubation catheter until the
blunt tip 107 of the dilator portion 106 of the tube changer device
100 is positioned substantially aligned with the distal portion 202
of the first intubation catheter. At step 308, the tube changer
device 100 is held in place. At step 310, remove the first
intubation catheter by sliding the first intubation catheter over
the tube changer device 100. At step 312, the second intubation
catheter is introduced by placing a distal end of a second
intubation catheter around the proximal end of the tube changer
device 100. At step 314, advance the second intubation catheter
guided by the tube changer device 100 until a distal portion of the
second intubation catheter surrounds the dilator portion 106 of the
tube changer device 100. At step 316, the second intubation
catheter is held in place. At step 318, remove the tube changer
device 100 from the second intubation catheter.
[0022] This method can be modified to be use the tube changer
device 100 in conjunction with a conventional stylet. For example,
before inserting the tube changer at step 304, a stylet 300 can be
advanced into the existing ETT using a traditional method. The
stylet 300 can be used as a guide. Step 304 of inserting a distal
end of the tube changer device into the proximal end of the lumen
of the first intubation catheter can include threading the tube
changer device 100 over the stylet 300. Step 318 of removing the
tube changer device from the second intubation catheter can include
removing the stylet 300 together with the tube changer device
100.
[0023] In another example, after determining that a first
intubation catheter placed in an airway of a patient requires
replacement, a stylet 300 can be inserted into the first intubation
catheter and advanced to a position. While holding the stylet 300
in position, the first intubation catheter can be removed by
sliding the first intubation catheter over the stylet 300. Next, by
inserting a distal end 102 of the tube changer device 100 into a
lumen 209 of a second intubation catheter until a blunt portion 107
of the dilator portion 106 of the tube changer device 100 is
positioned substantially aligned with the distal end 202 of the
second intubation catheter. Together, the tube changer device 100
within the second intubation catheter can be positioned around a
proximal end of the stylet 300, and advanced together. The tube
changer device 100 and the second intubation catheter can be guided
by the stylet 300 until the blunt portion 107 of the tube changer
device 100 reaches a position. While holding the second intubation
catheter 200b in position, the tube changer device 100 and stylet
300 can be removed, together, by sliding the tube changer device
100 through the lumen of the second catheter.
[0024] FIG. 4 shows an example method for placement of an ETT or
intubation catheter where the tube changer device 100 and ETT 200
are advanced together. At step 402, position the tube changer 100
into an ETT 200 such that the dilator portion 106 covers the side
opening 206 of the ETT 200 and bevel tip 203 is blunted by the
blunt tip 107 of the dilator portion 106. The tube changer device
100 is slidably received within a lumen of the ETT 200. The ETT 200
can be replacement intubation catheter. When used with a stylet as
a guide, at step 404, the stylet 300 can be positioned in the
airway. In the case of a tube exchange, where an existing ETT is
replaced, the stylet 300 can be inserted into an existing ETT and
held in place and the existing ETT is removed. At step 406, the
tube changer device 100 and the ETT 200 are advanced, together,
until ETT 200 is in position and properly placed. When used with a
stylet as a guide, the tube changer device 100 is threaded over the
stylet 300 and tube changer device 100 and the ETT 200 are
advanced, together, until ETT 200 is in position and properly
placed. At step 406, the ETT is held in place. At step 408, the
tube changer device 100 is removed from the ETT. When a stylet 300
is used, the tube changer device 100 and stylet 300 are removed,
together, from the ETT.
[0025] Although embodiments have been described herein in detail,
the descriptions are by way of example. The features of the
embodiments described herein are representative and, in alternative
embodiments, certain features and elements may be added or omitted.
Additionally, modifications to aspects of the embodiments described
herein may be made by those skilled in the art without departing
from the spirit and scope of the present invention defined in the
following claims, the scope of which are to be accorded the
broadest interpretation so as to encompass modifications and
equivalent structures.
* * * * *